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NCT Number: NCT07243288

Evaluation of an Early Radiomic Signature in Patients With Metastatic Pancreatic Adenocarcinoma Treated With First-line Chemotherapy

Pancreatic cancer, which has a poor prognosis, is becoming increasingly common in industrialized countries. Chemotherapy is the main treatment available for metastatic disease. Response to chemotherapy is currently assessed using imaging to monitor changes in the size of lesions undergoing treatment. Radiomics is a new method of analyzing quantitative data extracted from imaging that can be used to develop prediction algorithms and evaluate response to treatment. There is little robust radiomics data available for evaluating response to first-line treatments for pancreatic adenocarcinoma. Our main hypothesis is that quantifying tumor-related architectural changes could enable early identification of patients who will not respond to chemotherapy.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Cochin

Paris, 75014, France

About this study

Pancreatic adenocarcinoma is a cancer with a poor prognosis, and its incidence is increasing, particularly in industrialized countries. Systemic chemotherapy, the main treatment available, has improved survival in patients with metastatic pancreatic adenocarcinoma. Following the results of the study by Conroy et al., the combination of 5FU + oxaliplatin + irinotecan (FOLFIRINOX) is one of the standard first-line chemotherapy regimens for metastatic pancreatic adenocarcinoma.

The population of patients with metastatic pancreatic adenocarcinoma is heterogeneous, with different survival profiles. This is part of a multifactorial picture that is still poorly understood (molecular, terrain, other factors, etc.). Response to chemotherapy is currently assessed using the RECIST 1.1 method, which takes into account changes in the size of lesions during treatment. However, this method is sometimes limited, as it does not always take into account the underlying pathophysiology.

Radiomics consists of analyzing quantitative data extracted from imaging, which allows prediction algorithms to be developed. Several studies have suggested that tumor architecture could be a biomarker of response and survival in patients with esophageal, lung, or colorectal cancer.

A study of 41 patients with advanced pancreatic cancer treated with gemcitabine-based chemotherapy evaluated the impact of radiological architectural assessment on treatment response. The results showed that tumor size, asymmetry, and standard deviation of density at baseline were associated with progression-free survival, and that tumor size and standard deviation of density at baseline were associated with overall survival. These results remain to be confirmed in a larger population, hence the value of conducting our work with data from our database.

Our main hypothesis is that quantifying tumor-related architectural changes could enable early identification of patients who will not respond to treatment. The overall objective would be to tailor the therapeutic strategy to each individual patient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years)
  • Diagnosis of acute alcoholic hepatitis (ICD10 C25) in a pathology report, followed by manual verification in clinical documents

Exclusion criteria

  • Patients younger than 18 years at diagnosis

Treatment and study plan

Patients treated with FOLFOX or FOLFIRINOX in first line

Drug

Treatment with FOLFOX or FOLFIRINOX (chemotherapy protocols) in first line

Patients treated with GEMCITABINE in first line

Drug

Treatment with GEMCITABINE (chemotherapy protocols) in first line

Primary outcomes

  1. Overall survival after diagnosis of pancreatic cancer

    Time frame: From diagnosis up to 7 years after

    Overall survival will be assessed using mortality data recorded in the AP-HP Clinical Data Warehouse. The objective is to evaluate prognosis and identify risk factors associated with death after a diagnosis of pancreatic cancer, by integrating clinical, biological, histological and radiomics information. Survival will be analysed at multiple time points, including 1 month, 6 months, and 1 year after diagnosis.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: RADIOPAN

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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